FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
VM PLUS PEAK FLOWMETER
K Number: K962074
·
Decision Jan 2, 1997
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
6
Review Days
219
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Basic Information
- Device Name
- VM PLUS PEAK FLOWMETER
- K Number
- K962074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clement Clarke Intl., Ltd.
- Date Received
- May 28, 1996
- Decision Date
- January 2, 1997
- Product Code
- BZH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | FDA class 2 | Anesthesiology |
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Other Clearances by Clement Clarke Intl., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K053156 | MINI-WRIGHT DIGITAL, MODEL 3120001 | Jan 31, 2006 | Substantially Equivalent |
| K042058 | ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN | Mar 23, 2005 | Substantially Equivalent |
| K000368 | EYECAP IMAGING SYSTEM | May 4, 2000 | Substantially Equivalent |
| K982334 | AIRZONE PEAK FLOWMETER | Jan 14, 1999 | Substantially Equivalent |
| K980960 | IN-CHECK INSPIRATORY FLOWMETER | Jun 10, 1998 | Substantially Equivalent |